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NAHAM Patient Access Regulatory Issues Management
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NAHAM Patient Access Regulatory Issues Management Page


As part of NAHAM’s Strategic Plan, NAHAM’s Policy Development & Government Relations Committee is monitoring the following key regulatory issues identified as those affecting the day-to-day operations of Patient Access. This is not an exhaustive list and NAHAM members are welcome to suggest additional issues.

Last updated: September 12, 2018

Important Message from Medicare (IMM)


Hospitals are required to deliver the Important Message from Medicare (IM), CMS-R-193, to all Medicare beneficiaries (Original Medicare beneficiaries and Medicare Advantage plan enrollees) who are hospital inpatients. The IM informs hospitalized inpatient beneficiaries of their hospital discharge appeal rights. A Detailed Notice of Discharge (DND) is given only if a beneficiary requests an appeal. The DND explains the specific reasons for the discharge. 

 

In general, see CMS.gov: Hospital Discharge Appeal Notice.

See NAHAM CMS Survey Toolkit for additional information (III-8. Regulations and Guidance: Important Message from Medicare (IM or IMM)).


Questions regarding the IM and DND can be emailed to BNImailbox@cms.hhs.gov

 

Find the relevant regulatory text for Conditions of Participation: Patient's Rights at 45 Code of Federal Regulations 482.13.

 

 

Medical Outpatient Observation Notice (MOON)


Hospitals and CAHs are required to provide a MOON to Medicare beneficiaries (including Medicare Advantage health plan enrollees) informing them that they are outpatients receiving observation services and are not inpatients of a hospital or critical access hospital (CAH).

 

The MOON is mandated by the Federal Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act), passed on August 6, 2015. This law amended Section 1866(a)(1) of the Social Security Act by adding new subparagraph (Y) that requires hospitals and CAHs to provide written notification and an oral explanation of such notification to individuals receiving observation services as outpatients for more than 24 hours at the hospitals or CAHs.

Full instructions are available in Section 400 of Chapter 30 of the CMS Claims Processing Manual.  The final rule may be found in this Federal Register Notice of 8-22-2016.

 

Send specific questions regarding MOON to: MOONMailbox@cms.hhs.gov.

 

Useful downloads:

 

 

In general, see CMS.gov: Medical Outpatient Observation Notice (MOON)

See also NAHAM CMS Survey Toolkit for additional information (III-2. Regulations and Guidance: Medical Outpatient Observation Notice (MOON)).



Advance Beneficiary Notice of Noncoverage (ABN)


The Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, is issued by providers (including independent laboratories, home health agencies, and hospices), physicians, practitioners, and suppliers to Original Medicare (fee for service - FFS) beneficiaries in situations where Medicare payment is expected to be denied. The ABN is issued in order to transfer potential financial liability to the Medicare beneficiary in certain instances. Guidelines for issuing the ABN are published in the Medicare Claims Processing Manual, Chapter 30, Section 50.

In general, see CMS.gov: Fee For Service Advance Beneficiary Notice.

See also Medicare Advance Written Notices of Noncoverage (Medicare Learning Network, September 2017)

 

HIPAA Privacy & Release of Information with Business Associates


The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.

In general, see HHS.gov: The HIPAA Privacy Rule.

See also Summary of the HIPAA Privacy Rule.

See also HIPAA Basics for Providers: Privacy, Security, and Breach Notification Rules (Medicare Learning Network, August 2016).

See NAHAM CMS Survey Toolkit for additional information (III-1. Regulations and Guidance: HIPAA Notice of Privacy Practice).

See also NAHAM Joint Commission Survey Toolkit (VI. Other Resources and Links).

 

Emergency Medical Treatment and Labor Act (EMTALA)


In 1986, Congress enacted the Emergency Medical Treatment & Labor Act (EMTALA) to ensure public access to emergency services regardless of ability to pay. Section 1867 of the Social Security Act imposes specific obligations on Medicare-participating hospitals that offer emergency services to provide a medical screening examination (MSE) when a request is made for examination or treatment for an emergency medical condition (EMC), including active labor, regardless of an individual's ability to pay. Hospitals are then required to provide stabilizing treatment for patients with EMCs. If a hospital is unable to stabilize a patient within its capability, or if the patient requests, an appropriate transfer should be implemented.

In general, see CMS.gov: Emergency Medical Treatment & Labor Act (EMTALA).

See NAHAM CMS Survey Toolkit for additional information (III-9. Regulations and Guidance: Emergency Medical Treatment & Labor Act (EMTALA)).



Medicare Secondary Payer (MSP)


Medicare Secondary Payer (MSP) is the term generally used when the Medicare program does not have primary payment responsibility - that is, when another entity has the responsibility for paying before Medicare.

 

In general, see CMS.gov: Medicare Secondary Payer.

See NAHAM CMS Survey Toolkit for additional information (III-7. Regulations and Guidance: Medicare Secondary Payer (MSP)).

 

Find the relevant regulatory text for Exclusions from Medicare and Limitations on Medicare Payment at 45 Code of Federal Regulations Part 411.

 

501r Pricing Transparency


The Affordable Care Act (ACA), enacted March 23, 2010, added new requirements that hospital organizations must satisfy in order to be described in section 501(c)(3), as well as new reporting and excise taxes. Many of these provisions became effective as of the date of enactment. The Community Health Needs Assessment (CHNA) requirements, discussed below, became effective for tax years beginning after March 23, 2012.

In general, see IRS.gov: New requirements for 501(c)(3) Hospitals Under the Affordable Care Act.

See also Price Transparency in Health Care (report from the HFMA Price Transparency Task Force (2014).

 

See also HFMA Improving Pricing Transparency.



Advanced Directives

 

At the time of admission, patients must be given a written summary of their healthcare decision-making rights (form developed by the state) and the facility's policies with respect to recognizing advance directives.

 

The Federal Patient Self Determination Acti (enacted in 1990) addresses the rights of health (including mental health) care users to stipulate in advance how they would like to be treated by health care providers when they are incapacitated. These wishes can be articulated by consumers in a specific document (an advance directive) or by appointing someone as a health care agent to speak for them.

 

An advance directive is defined as a written instruction, such as a living will or durable power of attorney for health care, recognized under state law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated. The federal law does not require individuals to complete any form of advance directive and it specifically forbids requiring an advance directive as a requisite for treatment.

 

Find the relevant regulatory text for Notice of Privacy Practices of Protected Health Information at 45 Code of Federal Regulations 164.520.


CMS Documentation of Administrative Gender

 

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule for its 2015 Edition for health IT certification criteria.  The new criteria require Certified Electronic Health Record Technology (CEHRT) to include fields to capture the patient's "Administrative Gender" as either male (M), female (F) or unknown (UNK).  Specifically, beginning with the April 2016 annual release, eCQMs are required to use the HL7 V3 value set for AdministrativeGender (not AdministrativeSex) when specifying birth sex. 

 

The value set intent is to capture the biologic phenotypic sex that would be captured on the patient’s initial birth certificate. If the data is missing, it is not possible to determine the patient sex, or the patient’s birth certificate sex is undetermined, then one should use the nullFlavor “UNK” as is described above in race and ethnicity.

 

The CMS QRDA Implementation Guide provides additional guidance on how to use null values to describe race, ethnicity, and administrative sex data when the response is declined by the patient or is unknown.

 

See Identifying the Transgender Population in the Medicare Program (Transgender Health, Volume 1.1 2016), available as an Open Access article. 

 

See also NAHAM's Best Practices for Improved Patient Data Collection. 

 

 

 


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